Rosacea Review

Coadministering ivermectin 1% cream (Soolantra) with brimonidine 0.33% gel (Mirvaso) improved outcomes among patients with moderate to severe rosacea, according to a poster study presented by Linda Stein Gold, MD, and colleagues at the American Academy of Dermatology 2018 Annual Meeting.

The randomized, double-blind, vehicle-controlled trial included 190 participants with moderate to severe rosacea, of whom 91.1% were Caucasian. Participants were randomized to either once-daily ivermectin and once-daily brimonidine for 12 weeks (n=49), once-daily ivermectin for 12 weeks and once-daily brimonidine vehicle for 4 weeks followed by once-daily brimonidine for 8 weeks (n=46), or ivermectin vehicle and brimonidine vehicle for 12 weeks (n=95). Along with the study treatment, participants were recommended to use a daily skin care regimen that included a gentle cleanser, moisturizing lotion, and facial moisturizer with SPF 15 sunscreen.

The study used the Investigator’s Global Assessment (IGA) with success being a score of 0/1 (clear or almost clear) at week 12, 3 hours after brimonidine application. In addition, changes in IGA were assessed at each visit, 100% reduction in lesion count by week 12, changes in Clinical Erythema Assessment (CEA), and subject global improvement of rosacea, as well as monitored adverse events.

The total combined active group that received a combination of ivermectin and brimonidine showed superior efficacy at week 12 hour 3 compared with the vehicle group (55.8% vs 36.8%, respectively). Participants who received 12 weeks of treatment with brimonidine showed superior efficacy, with results seen as early as day 1, compared with those who received vehicle.

By week 4, changes in IGA were statistically significant among participants receiving ivermectin and brimonidine for 12 weeks. At week 12, the comparison of the effect before and 3 hours after application of brimonidine showed that the success rate among participants in the 12-week ivermectin and brimonidine group nearly doubled from 32.7% to 61.2% from hour 0 to hour 3, respectively.

Additionally, improvements in CEA were observed among participants receiving ivermectin and 12 weeks or 4 weeks of brimonidine compared with vehicle. After 12 weeks of treatment, 16.3% of participants who received 12 weeks of ivermectin and brimonidine achieved 100% reduction in lesion count.

The subject global improvement rate of excellent and good improvement was 77.7% among participants who received 12 weeks of ivermectin and brimonidine, 66.7% among participants who received ivermectin and 8 weeks of brimonidine, and 55.2% among participants who received vehicles.

Overall, 8 treatment-related adverse events occurred among 6 participants and 1 participant in the ivermectin and 8-week brimonidine group discontinued treatment due to allergic contact dermatitis on the chest. Treatment-related worsening of rosacea was observed in 1 participant in the ivermectin and 8-week brimonidine group and 3 in the vehicle group.

“Early introduction of [brimonidine] (from day 1), along with a complete daily skin care regimen, may exert additional efficacy benefit and accelerate treatment success without impairing tolerability,” the researchers concluded. “This regimen is a promising option for the comprehensive management of this complex disease.”

Rosacea was associated with an increased risk for developing depression and anxiety, according to a recent literature review by Heisig and Reich, published in Clinical, Cosmetic and Investigational Dermatology.

In their review, the researchers identified 13 studies on rosacea and depression or anxiety using the CINAHL and MEDLINE databases. They found that patients with rosacea have an increased risk for developing depression and anxiety and tended to avoid social situations. Men were more negatively impacted by the disease and reported more feelings of stigmatization compared with women. In addition, all treatment methods that improved rosacea symptoms were associated with better quality of life outcomes among patients. Adding psychological support, such as behavioral therapy, may improve patient outcomes as well, the researchers noted.

“The problem of stigmatization and psychosocial distress in rosacea is still underestimated, and it is important for clinicians to acknowledge the psychological impact of this disease to stimulate them to introduce more comprehensive treatment,” the researchers concluded.

Oxymetazoline cream was safe for the treatment of persistent facial erythema associated with rosacea, according to the findings of a recent study by Kuang and colleagues, published in the Journal of Drugs and Dermatology.

In the randomized, double-blind, parallel-group study, participants with moderate to severe erythema associated with rosacea were randomized to either once- or twice-daily oxymetazoline cream at 0.5%, 1.0%, or 1.5% doses or vehicle for 28 days. Plasma samples for pharmacokinetic analysis were collected from participants receiving oxymetazoline on day 1 prior to initiating treatment and 6 times after administering treatment on day 28.

The safety population for the study included 356 participants, 268 of whom were randomized to an oxymetazoline group and 88 to the vehicle group.

Overall, oxymetazoline was found to be safe, effective, and well tolerated at all concentrations. The mean maximum plasma concentrations were 115 pg/mL or greater across all groups, and the highest mean values for area under the plasma concentration-time curve from 0 to 24 hours posttreatment with once- and twice-daily oxymetazoline 1.5% were 1680 pg•h/mL and 2660 pg•h/mL, respectively. In addition, systemic exposure to oxymetazoline increased dose proportionally with once- and twice-daily administration.

Among participants who received oxymetazoline, 33 (11.2%) reported treatment-related treatment-emergent adverse events, of which most were mild to moderate application site reactions.

“These findings support the use of oxymetazoline for the treatment of persistent facial erythema associated with rosacea,” the researchers concluded.

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